(50 days)
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Not Found
No
The summary describes standard TENS/NMS electrodes and their biocompatibility and impedance characteristics, with no mention of AI or ML.
No
The device is described as "Transcutaneous Electrical Nerve (TENS) and Muscle Stimulation (NMS/FES) electrodes." While TENS and NMS are therapeutic modalities, the device itself is explicitly referred to as electrodes. Electrodes are components used with a therapeutic device (like a TENS unit), but they are not, in themselves, the therapeutic device. The "Summary of Performance Studies" also focuses on skin sensitivity and impedance of the gels and electrodes, not on their direct therapeutic effect.
No
This device is described as electrodes for Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMS/FES), which are therapeutic modalities for pain relief and muscle rehabilitation, not for diagnosing medical conditions. The performance studies focus on skin sensitivity and impedance, which relate to electrode safety and function, not diagnostic capabilities.
No
The device description explicitly states it is "Transcutaneous Electrical Nerve (TENS) and Muscle Stimulation (NMS/FES) electrodes," which are hardware components. The performance studies also focus on the biocompatibility and impedance of these physical electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator of the device's purpose. IVDs have specific intended uses related to diagnosing diseases or conditions using samples from the human body.
- Device Description: The description "Transcutaneous Electrical Nerve (TENS) and Muscle Stimulation (NMS/FES) electrodes" clearly indicates a device that applies electrical stimulation to the skin for therapeutic purposes, not for in vitro diagnostic testing.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies focus on skin sensitivity and electrode impedance, which are relevant to the safety and function of a TENS/NMS electrode, not an IVD.
Therefore, the information provided strongly suggests this device is a therapeutic device for electrical stimulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Repositionable TENS and EMS Electrodes with RG-60 Series Gel
Product codes
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Device Description
Transcutaneous Electrical Nerve (TENS) and Muscle Stimulation (NMS/FES) electrodes, which use RG-60 Series gel to adhere them to the skin.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The safety issues analyzed were skin irritation. The effectiveness of the electrodes was determined by comparing impedance levels.
The RG-60 Series gels used in this family of electrodes have passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance For Medical Devices. These tests include Cytotoxicity, Dermal Sensitization Study (Buehler Patch Test), Repeat Insult Patch Test, and Primary Skin Irritation Test. The gels used in the Uni-Patch TENS and Muscle Stimulation electrodes have already been used in cutaneous electrodes manufactured by Uni-Patch.
When measuring the electrodes impedance, driven at IK-Hz, Uni-Patch determined that the electrode impedance values were comparable to all the electrodes tested.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Uni-Patch Medical Supplies. The logo features a keyhole graphic to the left of the company name, "UNI-PATCH". Below the company name is the text "Medical Supplies". The logo is simple and clean, with a focus on the company name.
MAY 1 0 1996
510(k) Premarket Notification Repositionable TENS and EMS Electrodes with RG-60 Series Gel
SUMMARY OF SAFETY AND EFFECTIVE
Uni-Patch considers their Transcutaneous Electrical Nerve (TENS) and Muscle Stimulation (NMS/FES) electrodes to be as safe and effective as the Medtronic, Comfort-Ease", TENS & Neuro-Muscular Stimulation Electrodes, the 3M, Myocare®, Muscle Stimulation Electrodes, and the LMI TENS/EMS Electrodes with Promeon RG-60 Series gel of which were previously found to be substantially equivalent via a 510(k) Premarket Notification. The safety issues analyzed were skin irritation. The effectiveness of the electrodes was determined by comparing impedance levels.
The first safety issue was to determine if the gel, which is used to adhere the electrode to the skin, would cause any skin irritation. The RG-60 Series gels used in this family of electrodes have passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance For Medical Devices. These tests include Cytotoxicity, Dermal Sensitization Study (Buehler Patch Test), Repeat Insult Patch Test, and Primary Skin Irritation Test. The gels used in the Uni-Patch TENS and Muscle Stimulation electrodes have already been used in cutaneous electrodes manufactured by Uni-Patch. Therefore, Uni-Patch considers the RG-60 Series gels used in the manufacturing of their TENS and Muscle Stimulation electrodes to be acceptable for short-term contact with the skin.
There are no published performance standards for TENS or Muscle Stimulation electrodes, so Uni-Patch used impedance levels as the criteria for effectiveness testing. When measuring the electrodes impedance, driven at IK-Hz, we have determined that the electrode impedance values were comparable to all the electrodes tested.
Therefore, Uni-Patch considers its TENS and Muscle Stimulation electrodes (NMS/FES) to be as safe and effective as the Medtronic, Comfort-Ease', 3M, Myocares, and the LMI TENS/EMS Electrodes.
March 08, 1996